− Primary and Key Secondary Endpoints Were Met in Narcolepsy
Type 1 Phase 2b Trial
− TAK-861 Was Found to be Generally Safe and
Well-Tolerated
− Results Will be Presented at an Upcoming Scientific
Congress
Takeda (TSE:4502/NYSE:TAK) today announced
positive topline results from a randomized, double-blind,
placebo-controlled, multiple dose Phase 2b trial evaluating
TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with
narcolepsy type 1.
Narcolepsy is a chronic, rare neurological disorder of central
hypersomnolence with significant unmet need despite multiple
approved therapies. It is currently classified into two different
types: narcolepsy type 1 (NT1) caused by significant loss of orexin
neurons with resulting lack of orexin, and narcolepsy type 2 (NT2)
where orexin levels are generally normal. Stimulating the orexin
receptor 2 in NT1 patients targets the underlying pathophysiology
of the disease to restore orexin signaling. Two separate Phase 2b
studies were conducted in NT1 (NCT05687903) and NT2
(NCT05687916).
The NT1 trial TAK-861-2001 evaluating TAK-861 in 112 patients
demonstrated statistically significant and clinically meaningful
improvement in objective and subjective measures of wakefulness
compared to placebo at week 8 including on the primary endpoint
Maintenance of Wakefulness Test (MWT) (p < 0.001). Improvements
in key secondary endpoints including Epworth Sleepiness Scale (ESS)
and Weekly Cataplexy Rate (WCR) were statistically significant and
clinically meaningful, consistent with the primary endpoint. The
majority of patients who completed the trial entered a long-term
extension study. Based on these results, and in consultation with
global health authorities, Takeda plans to initiate global Phase 3
trials of TAK-861 in NT1 rapidly in the first half of its fiscal
year 2024.
At this time, Takeda does not plan to advance TAK-861 in NT2.
Data are being further analyzed to determine next steps in orexin
normal populations. Takeda is progressing multiple orexin agonists
in patient populations with normal levels of orexin neuropeptides
such as NT2 and other indications where orexin biology is
implicated.
TAK-861 was generally safe and well tolerated in both trials. No
treatment related serious adverse events were reported. In
addition, no cases of hepatotoxicity or visual disturbances were
reported in the Phase 2b trials or in the ongoing TAK-861 long-term
extension trial.
“We are thrilled to announce these clear and compelling results
from the TAK-861 trial in narcolepsy type 1 that allows us to
rapidly initiate Phase 3 trials this year as we work to deliver a
medicine to patients that could address the underlying
pathophysiology of the disease,” said Sarah Sheikh M.Sc., B.M.,
B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head,
Global Development at Takeda. “Takeda thanks the patients,
caregivers and investigators who participated in our orexin agonist
trials. We will continue to apply our deep and growing
understanding of orexin biology as we work to develop and deliver
transformative treatments to people across a range of indications
who could benefit from this mechanism.”
Results from both trials will be presented at an upcoming
scientific congress.
Results from the Phase 2b trials have no impact on the full year
consolidated reported forecast for the fiscal year ending March 31,
2024 (Fiscal Year 2023).
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
Important Notice
For the purposes of this notice, “press release” means this
document, any oral presentation, any question-and-answer session
and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited (“Takeda”) regarding this release.
This press release (including any oral briefing and any
question-and-answer in connection with it) is not intended to, and
does not constitute, represent or form part of any offer,
invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to
the public by means of this press release. No offering of
securities shall be made in the United States except pursuant to
registration under the U.S. Securities Act of 1933, as amended, or
an exemption therefrom. This press release is being given (together
with any further information which may be provided to the
recipient) on the condition that it is for use by the recipient for
information purposes only (and not for the evaluation of any
investment, acquisition, disposal or any other transaction). Any
failure to comply with these restrictions may constitute a
violation of applicable securities laws. The companies in which
Takeda directly and indirectly owns investments are separate
entities. In this press release, “Takeda” is sometimes used for
convenience where references are made to Takeda and its
subsidiaries in general. Likewise, the words “we”, “us” and “our”
are also used to refer to subsidiaries in general or to those who
work for them. These expressions are also used where no useful
purpose is served by identifying the particular company or
companies.
Forward-Looking Statements
This press release and any materials distributed in connection
with this press release may contain forward-looking statements,
beliefs or opinions regarding Takeda’s future business, future
position and results of operations, including estimates, forecasts,
targets and plans for Takeda. Without limitation, forward-looking
statements often include words such as “targets”, “plans”,
“believes”, “hopes”, “continues”, “expects”, “aims”, “intends”,
“ensures”, “will”, “may”, “should”, “would”, “could”,
“anticipates”, “estimates”, “projects” or similar expressions or
the negative thereof. These forward-looking statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those
expressed or implied by the forward-looking statements: the
economic circumstances surrounding Takeda’s global business,
including general economic conditions in Japan and the United
States; competitive pressures and developments; changes to
applicable laws and regulations, including global health care
reforms; challenges inherent in new product development, including
uncertainty of clinical success and decisions of regulatory
authorities and the timing thereof; uncertainty of commercial
success for new and existing products; manufacturing difficulties
or delays; fluctuations in interest and currency exchange rates;
claims or concerns regarding the safety or efficacy of marketed
products or product candidates; the impact of health crises, like
the novel coronavirus pandemic, on Takeda and its customers and
suppliers, including foreign governments in countries in which
Takeda operates, or on other facets of its business; the timing and
impact of post-merger integration efforts with acquired companies;
the ability to divest assets that are not core to Takeda’s
operations and the timing of any such divestment(s); and other
factors identified in Takeda’s most recent Annual Report on Form
20-F and Takeda’s other reports filed with the U.S. Securities and
Exchange Commission, available on Takeda’s website at:
https://www.takeda.com/investors/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other
forward-looking statements it may make, except as required by law
or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
different trademarks, for different indications, in different
dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240208344780/en/
Japanese Media Yuko Yoneyama
yuko.yoneyama@takeda.com +81 70-2610-6609
U.S. and International Media Chris Stamm
chris.stamm@takeda.com +1 617-374-7726
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
Von Mai 2023 bis Mai 2024